EDC Systems & Services

EDC Systems & Services

McDougall has developed eCRFs using numerous EDC platforms and supported development on additional ones. If you have not selected a platform, we will help you choose one that fits your requirements and budget. McDougall also services studies using Sponsors’ EDC systems. Please visit our Clinical Data Management page for further information on our data management services.

What is an EDC system?

An Electronic Data Capture (EDC) system is a software application that stores patient data collected in clinical trials. Data is usually first recorded on paper and is then transcribed into the system and saved in an electronic case report form (eCRF). However, similar to other industries, the majority of clinical trials are finally making the move from paper based records to electronic records in the form of EDC software. The main benefits of EDC software are:

  • Streamlining of data collection
  • Real-time, quicker access to data
  • Data Security
  • Data Quality & Accuracy
  • More cost effective than error prone and heavy resource based paper based systems
  • Maintains regulatory compliance more effectively than paper processes

What are common features of an EDC system?

While certain elaborate features may vary from system to system, the following functionality is the basis of every EDC solution.

eCRF Designer; a feature that is meant to imitate paper forms. This eliminates creating forms from scratch and promotes data standards.

Query Management; Most systems have auto-generated queries and the ability to manually add queries. The EDC system communicates with necessary personnel so that all queries are responded to and resolved by different roles before the data can be locked.

Data Export; there are export features available to easily extract patient data.

Data Entry; after a protocol is set up in the system, that data is entered into the appropriate forms automatically.

Reporting; some systems have built-in reporting that offer further study insight.

Role based Security; each user account has designated permissions, actions can only be carried out by roles with permission for that action or data.

 

What are some of the more common EDC systems on the market?

Omnicomm TrialMaster

TrialMaster Electronic Data Capture (EDC) Suite actually provides easy-to-use, eClinical tools. TrialMaster makes navigation easy. Site users are guided to enter only the data that is expected, which improves both speed and accuracy. All users can filter data based on form, visit or query status, and thus focus quickly on the areas of most importance. Responding to a query is as easy as replying to a chat message on your phone. Above and beyond typical EDC functions, TrialMaster can perform many tasks that were historically seen in clinical applications external to an EDC system. This includes randomization, clinical adjudication and links to imaging systems. Bringing these modules together provides a depth of functionality that offers unique business benefits including improved efficiency and communication across multiple business units, faster study completion, and a reduction in costly integration projects.

OpenClinica

OpenClinica is an open-source, web-based electronic Case Report Form for capturing and managing clinical trial data. It is optimized for the cloud to ensure that it is always at its maximum performance peak. Thus, you can expect to access your studies anytime and restore your data in the case of system failures. With a collaborative, drag-and-drop study designer for you and mobile-friendly forms for your sites and subjects, OpenClinica is more than just data capture. It’s a better experience. The result? Higher quality data for your study, at a low cost that makes budgeting easy, too. With every deployment: secure, high-performance cloud. Though OpenClinica is an open-source software, it is compliant with the industry regulations. Among the standards, it meets GCP and 21 CFR Part 11. The application has a comprehensive validation documentation and audit support as well. Furthermore, the OpenClinica supports team provides your research organization with a complete in-person and hands-on training.

Trialstat

Cloud-based platform that enables clinical research professionals to manage study data, prepare reports and design workflows.. TrialStat EDC integrates features such as IWRS, Medical Coding, ePRO, CTMS and Imaging, along with a configurable real-time reporting analytics portal, with real-time data exports, to simplify trial data collection and ensure efficient and timely analysis in a fully compliant, easy-to-use environment. With a focus on data analytics, TrialStat offers robust reporting and metrics across a single study, a program, or your entire research portfolio – providing all stakeholders relevant, customized, real-time insight into all aspects of study data and highlighting areas of risk or potential delays.

Medidata-Rave

Rave EDC is the cornerstone of the Medidata Rave Clinical Cloud, offering you fast implementation and maximum control to support studies of any size, length, or complexity. Rave EDC is proven by more than 17,000 studies (one-third ongoing today) and more than 4 million patient experiences. Our flexible architecture empowers clinical research teams to capture, cleanse, and manage study data, ensuring efficient trial execution across every phase of the clinical trial life cycle. You can even collect data across clinical and non-clinical sources and easily integrate it with Rave EDC.

Nextrials Prism

Nextrials flagship solution is Prism® – a fully integrated clinical trial management and EDC product that provides both standard data management functionality and value-added tools for clinical trial management. Prism® allows trial sponsors to manage a project and see current data and results in real time – accelerating data review, cleaning and analysis processes of clinical research projects. Prism® significantly improves all aspects of the clinical trial process, eliminating delays in study start-up, facilitating patient enrollment, providing clean, timely data for ongoing analysis, and accelerating data lock and analysis. Prism® combines ease-of-use with innovative features to provide a fresh solution for the collection and management of clinical trial data.

Dacima

DACIMA CLINICAL is an advanced electronic data capture (EDC) and clinical data management system (CDMS) for capturing, managing and reporting clinical research data optimizing data collection by efficiently streamlining clinical data collection process. The software has been designed to meet the needs of CROs and pharmaceutical companies, government agencies as well as research institutions and academic researchers. DACIMA CLINICAL offers unprecedented flexible allowing you to design databases for any of your organization’s clinical data collection needs, as well as the unique features required clinical trials, all from one platform.

Medrio

Medrio EDC Intuitive and Reliable Electronic Data Capture. Accelerate study build with an intuitive drag-and-drop interface and make mid-study changes without downtime. Boost data quality, manage studies without the need of external programmers, and enjoy a low total cost of ownership. Build studies rapidly with an intuitive and programming-free drag-and-drop interface. A typical Medrio study build takes just 2.8 weeks, compared to the 12-week industry average. Comfortably meet deadlines. Quickly and independently change, validate, and deploy mid-study changes without tech support or taking your study offline. Conveniently make modifications without additional fees. Empower your staff to enter data more rapidly and accurately with form rules like edit checks and skip logic. Calculated variables ensure that figures (BMI, imperial to metric, etc.) are always reliable. Medrio EDC meets or exceeds all global data collection regulations. From ICH/GCP and 21 CFR to GDPR and HIPAA, we give you the tools to focus on the trial with complete confidence that your data is compliant

Inform by Oracle

InForm Electronic Data Capture (EDC) System simplifies data collection, aggregation and analytics.  InForm EDC has more successful submissions to the FDA than any other EDC system. The InForm EDC platform is renowned for its trusted performance and scalability. It has been used in over 3,000 clinical trials worldwide.  InForm EDC’s interface and query management features drive efficiency through the clinical data management process.  Right up to submission, InForm eases the process with fully compliant CDISC SDTM exports.  The data summary and reconciliation reports were developed in a Cooperative Research and Development Agreement with the FDA.  InForm provides the leading functionality in electronic data management. InForm EDC’s flexible architecture and integration capabilities facilitate easy implementation. The deployment as a hosted solution reduces hardware cost, validation efforts and organizational impact. With a full suite of reporting and transfer features, the InForm EDC provides you with everything you need to run a clinical research study from setup to submission.

df-discover by dfnet

DFdiscover is our reliable, flexible, mature, and scalable data management software system for clinical trials data. We develop it, we use it for every clinical trial at DF/Net and we license it to clients who desire ultimate control over, unrestricted access to, and trust in the source of, their data. We provide international clinical trial data management, technical infrastructure, training, and ongoing support for projects focused on the betterment of public health. As a growing company, we have had the privilege of working on a number of large pivotal global health studies. Our continued success has been based on two factors: developing connections and relationships with people; and our ability to provide the right tools to connect people with their data.

Please visit our Clinical Data Management page for further information on our data management services.

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